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Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02839408
Recruitment Status : Unknown
Verified July 2016 by Jorge Gamonal, University of Chile.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Gamonal, University of Chile

Brief Summary:

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Dietary Supplement: Lactobacillus rhamnosus SP1 Drug: Azithromycin Other: Talc powder Procedure: Periodontal treatment Scaling and root planning Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Placebo Comparator: Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Other: Talc powder
Sachet containing talc powder and tablet containing talc powder

Procedure: Periodontal treatment Scaling and root planning
Experimental: Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Dietary Supplement: Lactobacillus rhamnosus SP1
Sachet containing Lactobacillus rhamnosus SP1

Procedure: Periodontal treatment Scaling and root planning
Experimental: Periodontal treatment, Antibiotic
Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
Drug: Azithromycin
Tablet containing 500mg Azithromicyn

Procedure: Periodontal treatment Scaling and root planning



Primary Outcome Measures :
  1. Differences of at least 1mm between groups for clinical attachment level changes [ Time Frame: baseline, 3, 6, 9 and 12 month ]

Secondary Outcome Measures :
  1. Differences between groups for probing depth changes [ Time Frame: baseline, 3, 6, 9 and 12 month ]
  2. Differences between groups for bleeding on probing changes [ Time Frame: baseline, 3, 6, 9 and 12 month ]
  3. Differences between groups for plaque index changes [ Time Frame: baseline, 3, 6, 9 and 12 month ]
  4. Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid [ Time Frame: baseline, 3, 6, 9 and 12 month ]
  5. Differences between groups for levels of periodontal pathogens changes [ Time Frame: baseline, 3, 6, 9 and 12 month ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 14 natural teeth, excluding third molars
  • 10 posterior teeth
  • 35 years old
  • 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically

Exclusion Criteria:

  • Periodontal treatment before the time of examination
  • Systemic illness
  • Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839408


Locations
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Chile
Faculty of Dentistry of University of Chile
Santiago, Chile
Sponsors and Collaborators
University of Chile

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Responsible Party: Jorge Gamonal, Prof, University of Chile
ClinicalTrials.gov Identifier: NCT02839408     History of Changes
Other Study ID Numbers: FONDECYT 1130570.b
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jorge Gamonal, University of Chile:
periodontitis
azithromycin
probiotic

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents